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U.S. Department of Health and Human Services

Class 2 Device Recall Drill Guide (guide, surgical, instrument)

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 Class 2 Device Recall Drill Guide (guide, surgical, instrument)see related information
Date Initiated by FirmNovember 09, 2012
Date PostedAugust 02, 2013
Recall Status1 Terminated 3 on June 05, 2015
Recall NumberZ-1871-2013
Recall Event ID 64985
510(K)NumberK071420 
Product Classification Guide surgical instrument - Product Code FZX
ProductDrill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to measure depth that the drills and taps are protruding into bone, which is measured by depth markings at the proximal end of the drills/taps relative to the proximal end of the drill guide. These devices were used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
Code Information 2520301, 2520307
Recalling Firm/
Manufacturer		 SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly MA 01915-6516
For Additional Information ContactNicole Baginski
978-232-3990
Manufacturer Reason
for Recall		Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result, drills and taps could not be directed down guides during surgery due to mechanical interference.
FDA Determined
Cause 2		Device Design
ActionSpine Frontier sent an Advisory Notice dated November 9, 2012, via email to all affected customers. Customers were advised that their FacetFuse Drill Guides need to be replaced. Customers were instructed to write their number ( included in the email) on the outside of the package and provide us with the tracking information. A replacement part has been sent out to you. If you have any further questions please call (978) 232-3990.
Quantity in Commerce13 drill guides
DistributionUS Distribution including Puerto Rico and the states of CO, KS, MA and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FZX
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